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临床试验/NCT06441136
NCT06441136招募中不适用

Characterizing the Impact of Presbyphonia on Social Interaction

Matthew R. Hoffman2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2025年1月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
25
试验地点
2
主要终点
The Effect on Loneliness with the PhoRTE Voice Therapy Program

研究概览

简要总结

The purpose of this study is to determine if presbyphonia, or voice disorder caused by age-related change in the larynx, is associated with change in social interaction. This proposal investigates the impact of voice impairment in older adults on social interaction, loneliness, social disconnectedness, and depression. A series of questionnaires, voice assessments, and interviews will be performed to improve our understanding of how voice disorders affect older adults and how treatment of voice impairment with voice therapy may improve quality of life.

详细描述

During the study visit, all subjects (including the control group) will be given ten questionnaires asking them to rate their loneliness and quality of life in relation to the changes in their voice. All participants will undergo audiometry to assess hearing (with hearing aids if used at home). If they do not pass the hearing test, they will be screened out of the study.

Participants will then provide a required voice sample using sustained vowels for 3-5 seconds 5 times each, repeating six standard sentences, and 20 seconds of natural conversational speech. Using this voice recording, the following assessments and measurements will be obtained: CAPE-V rating (Consensus auditory perceptual evaluation of voice), Cepstral peak prominence (measurement of dysphonia), fundamental frequency, signal-to-noise ratio, and voice type components (captures breathiness).

Subjects will then be asked to produce a train of /pi pi pi/ at a comfortable pitch and loudness into a mask with an intra-oral mouthpiece to record both pressure and airflow. Five trials will be performed. The following measurements will be obtained: mean flow rate, subglottal pressure, and vocal efficiency.

Subjects will then undergo an awake videostroboscopy using a small flexible camera passed through the nose to view the vocal folds. During this procedure, the nose is anesthetized and the subject is asked to produce sustained vowels for 3-5 seconds. This part of the study takes about 2 minutes to complete. The parameters to be measured for this are: bowing index of the vocal folds and normalized glottal gap.

For the second part of this study, subjects from the presbyphonia population only will be recruited to participate in the phonation resistance training exercises or PhoRTE voice therapy. Prior to therapy, for two weeks, participants will take pictures when their voice disorder may be affecting them or ability to socialize. Brief journal entry will be completed. Photos will be collected, printed, and used as memory recall tool for a pre-treatment semi-structured interview. Interviews will be conducted, approximately 45-60 minutes induration. Both online and in-person options will be available to facilitate participation. An interview guide will include questions designed to assess participants' perception of voice and how voice affects social participation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of presbyphonia with findings of presbylaryngis on videostroboscopy, with findings of bilateral true vocal fold atrophy and normal vocal fold motion bilaterally
  • Able to complete all questionnaires and voice assessment tasks
  • Normal to mild hearing loss in aided condition (with hearing aids)

排除标准

  • Liquid dysphagia or pneumonia in the last year
  • Vocal fold lesion/scar/motion impairment
  • Neurologic disorder affecting the voice
  • Montreal cognitive assessment score <26 or <25 if 12 or fewer years of formal education

结局指标

主要结局

The Effect on Loneliness with the PhoRTE Voice Therapy Program

时间窗: Baseline and at 3 months

Loneliness will be measured using the University of California - Los Angeles (UCLA) Loneliness Scale questionnaire at baseline and at the end of the 4-week PhoRTE program. The UCLA Loneliness Scale is a 20-item scale with each item rated on a 4-point Likert scale (ranging from 1, "never," to 4, "often") and the total score can range from 20 to 80, with higher scores indicating greater feelings of loneliness.

次要结局

  • The Effect on Social Disconnectedness with the PhoRTE Voice Therapy Program(Baseline and at 3 months)
  • The Effect on Depression with the PhoRTE Voice Therapy Program(Baseline and at 3 months)

研究者

发起方
Matthew R. Hoffman
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Matthew R. Hoffman

Assistant Professor

University of Iowa

研究点 (2)

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